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Off-label Drug Use

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Ieva Butkute

on 26 July 2010

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Transcript of Off-label Drug Use

A study published in May, 2006 in the Archives of Internal Medicine evaluated 275 prescriptions written in 2001 and found that 21% of them were off-label. More importantly, 73% of those off-label prescriptions were for a use that lacked any firm scientific evidence. 1 2 Since off-label prescriptions are written without good medical support, patients using those medications are more likely to experience adverse side-effects. video: http://www.sciencemag.org/cgi/content/full/322/5899/209b Studies have shown that most doctors don't always know about the detailed labeling of a drug and its "approved" use. Rather, they rely on their colleagues in their prescribing habits. community standards of practice The common breast cancer drug Femara is prescribed off label to 3 in 10 women battling infertility even though there has not been enough evidence to show that it is safe and effective when used for that purpose. On the contrary, it is classified by the FDA as posing a pregnancy risk. According to one study of 150 babies, doctors' failure to abide by these regulations resulted in a three-fold increase in birth defects that were noted after Femara treatment.

The most common drugs prescribed unsafely or ineffectively off-label are antidepressants and antipsychotics. What are they? Off-label drugs are medications prescribed by doctors for purposes other than those expressly approved by the Food and Drug Administration (FDA). Drugs are most often prescribed off-label for children and pregnant women...
3 1 in 5 prescriptions in the United States are not approved by the FDA. Off-label drugs are not FDA approved, which means that they are not tested for efficacy and safety. 4 Susan Dudley, a nurse, became depressed and suicidal after taking a medication prescribed to her for nerve pain. Little did she know that that the drug was an epilepsy medication and was not approved for such use. Pharmaceutical companies must pay hundreds of millions of dollars to settle allegations of illegal marketing of drugs for off-label uses. Off-label drugs may not be covered by patient's insurance companies. The End IEVA BUTKUTE RITI CHOKSHI FF-LABEL DRUGS Why should they not be used? CLASS OF DRUG EXAMPLES OF OFF-LABEL USE anti-seizure drugs migraines, depression antidepressants chronic pain, ADHD, bipolar disorder beta-blockers (for high blood pressure and heart disease) migraines, anxiety Drugs Commonly Prescribed Off-Label Medicaid programs and other state medical support programs do not reimburse drugs prescribed to patients for off-label uses. Off-label use of drugs can create uneccesary costs both to the pharmaceutical company and the patient, putting both in DID YOU KNOW DID YOU KNOW SOLUTION Drugs should be prescribed off- label if and only if there are no other means of treatment available. In other words they can be considered as an option when none seem to be left. ...because they are routinely excluded from trials.
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